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Monoclonal Antibodies

Atezolizumab + Bevacizumab for Liver and Lung Cancers

Phase 2
Recruiting
Led By Adrian Sacher, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NSCLC patients must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type
Be willing to provide tumor tissue from a core biopsy of a tumor lesion (archival not acceptable)
Must not have
Has active Bacillus Tuberculosis (TB)
History of idiopathic pulmonary fibrosis, organizing pneumonia (eg. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how well atezolizumab works with or without bevacizumab in people with liver or lung cancer that has spread to the liver.

Who is the study for?
Adults with inoperable liver cancer or non-small cell lung cancer that has spread to the liver, who have adequate organ function and are not pregnant. NSCLC patients must be EGFR/ALK wild type and HCC patients may have had prior treatments. Participants need a measurable lesion, controlled hepatitis B or C, an ECOG performance status of 0 or 1, and agree to use effective contraception.
What is being tested?
The trial is testing the effectiveness of Atezolizumab alone or combined with Bevacizumab for treating liver cancer or lung cancer with liver metastases by monitoring how long it takes for participants' cancers to worsen after starting treatment. It also involves analyzing blood and tumor tissue samples before and after administration.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, high blood pressure due to Bevacizumab's effect on blood vessels, infusion reactions from both drugs, increased risk of infections, bleeding complications, fatigue, and possible interference with wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My NSCLC does not have mutations in EGFR or ALK genes.
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I agree to provide a fresh sample of my tumor for the study.
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My liver is functioning well despite my liver cancer.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My NSCLC has a high PD-L1 score or I haven't had chemotherapy.
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I have liver cancer or lung cancer with liver spread that can't be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have active tuberculosis.
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I have a history of specific lung conditions or signs of lung inflammation on a recent CT scan.
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My blood pressure is not well controlled, even with medication.
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I am currently in a clinical trial or was in one within the last 4 weeks.
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I have not received a live vaccine within 30 days before starting the study or won't need one during or within 5 months after treatment.
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I have had severe hypertension or brain issues due to high blood pressure.
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I haven't had major surgery or significant injury in the last 28 days, and my wounds are fully healed.
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I take NSAID medication every day for a chronic condition.
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I have recovered from previous treatment side effects to my normal health level or with mild symptoms.
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I have or had lung inflammation not caused by an infection.
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I have been diagnosed with HIV.
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I have pain from my cancer that isn't relieved by treatment.
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I have been treated with specific immune therapies or bevacizumab before.
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I have a serious wound or bone fracture that is not healing.
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I have had a severe blood clot in my veins.
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I have not had a transplant, immunodeficiency, or taken immunosuppressive drugs in the last 7 days.
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I have not had certain cancer treatments within the specified time before the trial starts.
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My cancer is a specific type called fibrolamellar HCC, mixed cholangiocarcinoma, or sarcomatoid HCC.
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I have untreated or partially treated varices in my esophagus or stomach that are at high risk of bleeding.
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I have no allergies to Atezolizumab or Bevacizumab or similar drugs.
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I do not have a bleeding disorder that increases my risk of bleeding.
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My cancer is growing into or very close to major blood vessels.
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I have a serious wound that won't heal, an active ulcer, or an untreated broken bone.
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I have had brain function issues due to liver disease or visible fluid in my abdomen recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (Lung Cancer)Experimental Treatment1 Intervention
Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks
Group II: Arm B (Lung Cancer)Experimental Treatment2 Interventions
Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks Bevacizumab: 15 mg/kg, intravenously (IV), every 3 weeks
Group III: Arm A (Liver Cancer)Experimental Treatment2 Interventions
Atezolizumab: 1200 mg, intravenously (IV), every 3 weeks Bevacizumab: 15 mg/kg, intravenously (IV), every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,524 Previous Clinical Trials
503,168 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,458 Previous Clinical Trials
1,097,899 Total Patients Enrolled
Adrian Sacher, MDPrincipal InvestigatorPrincess Margaret Cancer Centre

Media Library

Liver Metastases Research Study Groups: Arm A (Liver Cancer), Arm B (Lung Cancer), Arm C (Lung Cancer)
~0 spots leftby Dec 2024
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